(BPT) – For weeks, Nichol Miller had been looking forward to a local 5K obstacle course run. It was September 2014. Her husband Marc and some friends were running the race and Nichol was excited to cheer them on.
Then something happened.
“The next day, I could hardly walk,” said the 45-year-old Oregon mother of three. “My leg was sore and there was a large knot in my thigh. It hurt so badly that I went to my doctor and she sent me to the local hospital for a CT scan.”
Before Nichol left the hospital, she got a call from her doctor, asking her to return to the office.
“I knew from her voice that it wasn’t good. I went back to her office and she told me that it was most likely a tumor,” said Nichol. “When you hear those words, it’s like the floor falls out from under you. Everything was suddenly draped with a cloud of uncertainty.”
Nichol was diagnosed with soft tissue sarcoma. She started chemotherapy and planned to follow treatment with radiation therapy. But after two rounds of chemotherapy, the tumor had grown so large it could not be treated with radiation.
Nichol underwent surgery to remove the tumor in her left hip flexor, and she and Marc hoped the journey was over. Then a new CT scan showed a shadow in Nichol’s lungs. For the second time, the floor fell out from under them.
“At that point, we already knew that chemotherapy wouldn’t work. We did not know what to do,” said Nichol.
Finding answers inside the tumor
Nichol’s doctor had ordered genomic testing on her tumor at the time of her diagnosis. With her cancer growing worse, her doctor re-examined the results, searching for options. They learned from her genomic testing results that her tumor tested positive for a genomic abnormality called a NTRK gene fusion.1
Her doctor searched a clinical trial registry website and found a clinical trial testing a drug that was a match for the genomic makeup of Nichol’s tumor. The closest trial site was in Denver.
Marc and Nichol traveled the 700+ miles from Oregon to Denver. By then, the shadow in Nichol’s lungs had grown so much that it filled about 90 percent of her lungs. She was on oxygen and needed a wheelchair. After she arrived at the hospital, she was treated with antibiotics. Once she recovered, she was eligible to be enrolled in the clinical trial.
The doctors in charge of the clinical trial then started her on the study medication, Vitrakvi® (larotrectinib). Vitrakvi was approved by the U.S. Food and Drug Administration to treat adults and children with solid tumors (cancer) that are caused by certain abnormal NTRK genes, and have spread or if surgery to remove their cancer is likely to cause severe complications, and there is no acceptable treatment option or the cancer grew or spread on other treatment in November 2018.2
Healthcare providers will perform a test to make sure that VITRAKVI is right for you. It is not known if VITRAKVI is safe and effective in children younger than 1 month of age.2
Vitrakvi is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in other clinical trials.2
Vitrakvi may cause serious side effects including nervous system problems and liver problems.2 The most common side effects with Vitrakvi include tiredness, nausea, dizziness, vomiting, cough, constipation, diarrhea. Please see more information below; these are not all the possible side effects. Talk to your healthcare provider for more information.2
After each week of treatment, as part of the study protocol, Nichol would go to the clinic every Saturday for blood work.
“As I continued to go to the clinic, my doctors could see that the tumor was shrinking,” said Nichol. “My doctors could see that Vitrakvi was working for me.”
“Nichol is a good example of why testing the makeup of a patient’s tumor is so important. Genomic sequencing identified an alteration in her tumor, and opened the opportunity for her to be in the larotrectinib clinical trial,” said Dr. Lara Davis, Nichol’s oncologist at Oregon Health & Science University. “Although alterations like the one in Nichol’s tumor are uncommon, when one is identified it can make a major and important difference in that individual’s treatment and prognosis.”
Four weeks into the clinical trial, Nichol recalls the thrill of taking her children to the movies and getting to celebrate her birthday.
Nichol has become an advocate for anyone diagnosed with cancer. She wants them to hear this important message:
“Get your tumor genomically tested. Talk to your doctor and ask these two questions: Are there any tests that can be done to show what may be causing my tumor’s growth? And are there any treatments or clinical trials available that are appropriate for my tumor?”
This is the story of one cancer patient’s experience with Vitrakvi® (larotrectinib). Not all patient experiences will be the same.
What is VITRAKVI®?
VITRAKVI (larotrectinib) is a prescription medicine that is used to treat adults and children with solid tumors (cancer) that:
- are caused by certain abnormal NTRK genes and
- have spread or if surgery to remove their cancer is likely to cause severe complications, and
- there is no acceptable treatment option or the cancer grew or spread on other treatment.
Your healthcare provider will perform a test to make sure that VITRAKVI is right for you.
It is not known if VITRAKVI is safe and effective in children younger than 1 month of age.
VITRAKVI is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in other clinical trials.
Important Safety Information
VITRAKVI may cause serious side effects, including:
- Nervous system problems. Tell your healthcare provider if you develop any symptoms such as confusion, difficulty speaking, dizziness, coordination problems, tingling, numbness, or burning sensation in your hands and feet. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop symptoms of a nervous system problem with VITRAKVI.
- Liver problems. Your healthcare provider will do blood tests to check your liver function during treatment with VITRAKVI. Tell your healthcare provider right away if you develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of your stomach area. Your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop VITRAKVI if you develop liver problems with VITRAKVI.
Before taking VITRAKVI, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have nervous system (neurological) problems
- are pregnant or plan to become pregnant. VITRAKVI can harm your unborn baby. You should not become pregnant during treatment with VITRAKVI.
- If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with VITRAKVI.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 1 week after the final dose of VITRAKVI. Talk to your healthcare provider about birth control methods that may be right for you.
- Males with female partners who are able to become pregnant should use effective birth control during treatment with VITRAKVI and for at least 1 week after the final dose of VITRAKVI.
- are breastfeeding or plan to breastfeed. It is not known if VITRAKVI passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VITRAKVI
- VITRAKVI may affect fertility in females and may affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
While on VITRAKVI, you should avoid:
- driving or operating machinery until you know how VITRAKVI affects you. VITRAKVI can make you feel dizzy.
- taking St. John’s wort, eating grapefruit, or drinking grapefruit juice during treatment with VITRAKVI.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, vitamins, and herbal supplements. Certain other medicines may affect how VITRAKVI works.
The most common side effects with VITRAKVI include:
These are not all the possible side effects with VITRAKVI. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For full prescribing information, visit: http://labeling.bayerhealthcare.com/html/products/pi/vitrakvi_PI.pdf
- Amatu A, Sartore-Bianchi A, Siena S. ESMO Open. 2016;1(2):e000023.
- Vitrakvi® (larotrectinib) capsules and solution for oral use [Patient Prescribing Information]. Stamford, CT: Loxo Oncology Inc.; November 2018.
© 2018 Bayer. Bayer, the Bayer Cross and Vitrakvi are registered trademarks of Bayer.